Reduce Error,  Save Time

Don’t waste time using error-prone methods to achieve compliance. Manually converting data or building custom, hard-to-maintain macros is no longer sustainable and may put your study at risk. Let the Ponemah SEND* Module automatically convert your Ponemah data to a SEND 3.1-compliant format, with full traceability.

Supported SEND domains:

• ECG Test Results – EG
• Cardiovascular Test Results – CV
• Respiratory Test Results – RE
• Vital Signs – VS

*Standard for Exchange of Non-clinical Data (SEND) is a data formatting standard required for certain Safety Pharmacology, General Toxicology and Reproductive Toxicology studies for submission to the FDA.

 

 Ultimate Flexibility

We understand the SEND output from Ponemah is a small piece of your complete FDA submission. Don't worry about how you're going to attach your data to your submission. Ponemah SEND offers seamless data access to Laboratory Information Management Systems (LIMS) and SEND submission software. Microsoft Excel output is also available.

Compatible integrations:

• Instem Provantis™ and submit™
• Xybion Pristima™

 

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Don't be afraid of changing CDISC* Standards for SEND format requirements. Easily stay compliant with the latest SEND Controlled Terminology or required Parameter using Ponemah's Controlled Terminology Manager.

*The Clinical Data Interchange Standards Consortium (CDISC) convenes a global community of research experts representing a range of experiences and backgrounds. CDISC develops and advances data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a powerful framework. Learn more about CDISC standards at cdisc.org/standards.

 

 

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Don't have access to the integration or using your own in-house application? No problem! Use the Ponemah SEND Viewer to review and export your data for easy import into the system of your choice.